Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

February 14, 2023 updated by: Cipherome, Inc.

Pharmacogenomic Analysis of 6-mercaptopurine in Pediatric Acute Lymphoblastic Leukemia

This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.

Study Overview

Status

Completed

Conditions

Detailed Description

The study objective is to clinically validate that the presence of recently discovered novel genetic variation adversely affects a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients using biobank samples.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population are pediatric patients, under 21 years of age, diagnosed with acute lymphoblastic leukemia patients between April 20, 2012 to August 6, 2020, and received 6-mercaptopurine for therapeutic purposes. All patients were recruited by the investigators at Stanford University Lucile Packard Children's Hospital.

Description

Inclusion Criteria:

  • Pediatric acute lymphoblastic leukemia (ALL) subjects
  • Received 6-mercaptopurine
  • Available biobank (bone marrow or blood) sample(s) from which deoxyribonucleic acid (DNA) can be extracted
  • White blood cell (WBC) levels

Exclusion Criteria:

  • Pediatric ALL subjects who did NOT receive 6-mercaptopurine
  • No biobank sample
  • No WBC level

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pediatric ALL patients on 6-mercaptopurine
Pediatric ALL patients treated with 6-mercaptopurine who did not experience neutropenia.
Pediatric ALL patients on 6-mercaptopurine with neutropenia
Pediatric ALL patients treated with 6-mercaptopurine who experienced neutropenia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Novel genetic variants impact on 6-mercaptopurine adverse drug reactions
Time Frame: 1 year
Objective is to clinically validate the presence of novel genetic variants and its impact on adverse drug reactions in a population of pediatric ALL patients treated with 6-MP
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating relationship of genetic variants to ancestry
Time Frame: 1 year
A secondary objective of this study is to compare the impact of the novel genetic variants with other known genetic variants contributing to ADR risk.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cipherome, Inc.

Collaborators

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

November 10, 2021

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C04-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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